FOCETRIA EMEA PDF
May 25, 2020 | by admin
to the European Medicines Agency (EMEA) for Focetria as an H5N1 . Focetria is a pandemic influenza vaccine, surface antigen, inactivated. Focetria. Scientific conclusions and grounds recommending the variation to the terms of the marketing EMEA/H/C//PSUV/ following assessment of the H1N1 data available with Focetria in children, In the context of variation EMEA/H/C//II/ (commission.
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For information on the CHMP’s recommendations, see the press release. The extension was proposed by the marketing authorisation holder to the Medical Products Agency MPA of Sweden, which is the reference Member State for Relenza, and agreed by other Member States via the mutual recognition procedure. This advice was based on a information indicating that influenza activity worldwide has returned to levels that are normally seen for seasonal influenza.
The Coordination Group for Mutual Recognition and Decentralised Procedures — Human CMD h recommends that Relenza that is already on the market or in people’s homes may — in the event of an influenza pandemic being officially declared by the World Health Organisation WHO — be used for up to two years after its current expiry date.
The latest data show no unexpected serious safety issues. Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products. The benefit-risk balance of the pandemic vaccines and antivirals used for the current H1N1 influenza pandemic continues to be positive.
For more information on Pandemrix, see the European public assessment report. Following the World Health Organization’s announcement that the world has moved into a post-pandemic period, the European Medicines Agency has published the last of its pandemic pharmacovigilance updates.
Expand all Collapse all. For more information on Tamiflu, see the European public assessment report. For more information, see the product information showing the recommended changes for CelvapanFocetria and Pandemrix.
For more information, see the revised document: This recommendation was based on data from clinical and non-clinical studies, from post-marketing surveillance and from the use of these vaccines in at least 40 million people in the European Economic Area since September No vaccines are currently available for this novel virus. For more information, see the CHMP opinion on the conditions of use, conditions for distribution and target population and information on compassionate use. The European Commission has granted authorisations that will allow the influenza vaccines Focetria and Pandemrix to be used to vaccinate people against the virus causing the current H1N1 influenza pandemic.
Pandemic influenza: news archive
While most countries will not be affected at this stage, the declaration of Phase 5 is a strong signal that a pandemic is imminent and that the time to finalize the organization, communication, and implementation of the planned mitigation measures is short. Additional clinical trials in adults emex children are currently being initiated by the vaccine manufacturers and the results will be reviewed in the coming months as they become available.
Influenza, Human Immunization Disease Outbreaks. The European Medicines Agency’s Committee for Medicinal Products for Human Use CHMP has adopted recommendations to update the product information for Tamiflu oseltamivir with more information on the medicine’s use in children over six months of age and in pregnant and breastfeeding women. As vocetria of its review of data from clinical studies and post-marketing experience for centrally authorised pandemic influenza vaccines, the Agency’s Committee for Medicinal Products for Human Use CHMP has recommended changes to the product information of Celvapan to include additional information on the vaccine’s immunogenicity and safety.
The temporary distribution of an additional device for the use of Relenza was proposed by the marketing authorisation holder to the Medical Products Agency MPA of Sweden, which is the reference Member State for Relenza.
It is intended for a target population that is different from that of Relenza, which is inhaled. They also include information on the evolution of the H1N1 pandemic, the number of doses of vaccines and antivirals distributed or administered in Europe, and the medicines’ benefits and risks. For more information, see the press releasequestions and answersopinion and assessment report.
Focetria | European Medicines Agency
Although an influenza pandemic has not been declared, the World Health Organization WHO increased the pandemic alert from level 3 to level 4 on 27 April in response to this outbreak. Once formally approved by the European Commission, this will apply to all newly manufactured Tamiflu capsules.
Tamiflu IV is an unauthorised medicine that is a new development of oseltamivir for intravenous use. For more gocetria on Celvapan, see the European public assessment report. For full details, see the EU recommendation for the emergent novel H1N1 influenza vaccine composition. For more information, see the CMD h meeting report. The European Medicines Focehria has recommended that the shelf life of Tamiflu capsules should be extended from five to seven years.
CHMP recommendations for the pharmacovigilance plan as part of the risk management plan to be submitted with the marketing authorisation application for a pandemic influenza vaccine. Standard paediatric investigation plan for non-adjuvanted or adjuvanted pandemic influenza vaccines during a pandemic.
For further details, see the guidance document: Focertia addition, the Committee has also recommended the approval of detailed instructions on the preparation and dosing of ‘extemporaneous’ formulations for children under the age of one.
The Agency’s Committee for Medicinal Products for Human Use CHMP has recommended that Tamiflu capsules that are already on the market may be used for up to two more years after their current expiry date during a declared pandemic.
The European Medicines Agency has published the third in its series of weekly pandemic influenza pharmacovigilance update reports. Patients who have Relenza that has recently expired should not throw it away, as it might be needed during a declared influenza pandemic.
To date, no unexpected serious safety issues have been identified.
An extemporaneous formulation of a medicine is a formulation that is prepared just prior to use. Relenza is currently authorised in all 27 European Union Member States, plus Iceland, Liechtenstein and Norway to treat or prevent influenza in adults and children from the age of five years onwards.
Among the antiviral medicines that are authorised in the European Union EU for use in an influenza outbreak, the neuraminidase inhibitors Tamiflu oseltamivir and Relenza zanamivir have shown effectiveness against the novel influenza virus.
By this date, at least This medicine will be used to treat critically ill patients with a life-threatening condition due to suspected or confirmed pandemic or seasonal flu, who cannot be treated with other antiviral medicines by mouth or inhalation.
More information on Focetria. The other two vaccines, Arepanrix and Humenza, have not been marketed in the EU. These updates, which have been published regularly since Decemberprovide a summary of the adverse drug reactions reported in people receiving vocetria centrally-authorised pandemic-influenza vaccines and antivirals in the European Union EU. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.
The Commission’s decision follows the scientific recommendations adopted in respect of these vaccines by the European Medicines Agency’s Committee for Medicinal Products for Human Use on 24 September The Agency also recommended further changes to the product information for Focetria and Pandemrix. The recommended changes are based on guidance adopted by the CHMP in May on the use of antiviral medicines during an influenza pandemic.